Inbrija 33 mg powder for inhalation hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Inbrija 33 mg inhalation powder, hard capsules

levodopa

Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Inbrija is and what it is used for
2. What you need to know before using Inbrija
3. How to use Inbrija
4. Possible side effects
5. How to store Inbrija
6. Contents of the pack and other information

1. What Inbrija is and what it is used for

The active substance in Inbrija is levodopa. Inbrija is an inhaled medication used to treat the worsening of symptoms during OFF periods in Parkinson's disease.

Parkinson's disease affects movement and is treated with a medication that you take regularly. During OFF periods, your usual medication does not control the disease adequately, and movement is likely to become more difficult.

You must continue taking your regular Parkinson's disease medication and use Inbrija to manage the worsening of symptoms (such as difficulty moving) during OFF periods.

2. What you need to know before using Inbrija

Do not use Inbrija

• if you are allergic to levodopa or to any of the other ingredients of this medicine (listed in section 6).
• if you have blurred vision, red eyes, severe eye or head pain, see halos around lights, your pupils are larger than usual, or feel dizzy. If you experience any of these symptoms, you may have narrow-angle glaucoma, a condition that occurs suddenly: stop taking Inbrija and seek immediate medical attention.
• if you have a rare adrenal gland tumor called pheochromocytoma.
• if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g., isocarboxazid and phenelzine). You must stop taking these medicines at least 14 days before starting treatment with Inbrija. See also "Other medicines and Inbrija".
• if you have previously experienced neuroleptic malignant syndrome, a potentially life-threatening reaction to certain medicines used to treat serious mental disorders, or if you have had non-traumatic rhabdomyolysis, a rare muscle disorder in which muscles break down rapidly.

Warnings and precautions

Seek immediate medical attention if you experience tremors, agitation, confusion, fever, rapid pulse, dizziness or fainting upon standing, or if you notice extreme muscle rigidity or severe muscle spasms. These may be symptoms of "drug withdrawal hyperpyrexia". For more information, see section 4.

Consult your doctor or pharmacist before starting Inbrija if you have, have had, or develop:

• asthma, breathing difficulties such as chronic obstructive pulmonary disease (COPD) or other lung diseases, or prolonged respiratory problems;
• any form of serious mental disorder, such as psychosis;
• a heart attack or heart rhythm problems. Your doctor will monitor you closely when starting treatment;
• a stomach or intestinal ulcer;
• an eye disorder called glaucoma, as eye pressure should be monitored in this case;
• severe kidney problems;
• severe liver problems.

If you are unsure whether you have any of the symptoms listed above, consult your doctor or pharmacist before using Inbrija.

Consult your doctor or pharmacist if you develop any of the following symptoms while using Inbrija:

• sudden attacks of sleepiness or feel unusually sleepy;
• changes or worsening in your mental state that may be serious, such as psychotic or suicidal behavior;
• hallucinations, along with confusion, difficulty sleeping, or vivid dreams. Changes in mental function such as anxiety, depression, agitation, paranoia, delusional thoughts, disorientation, aggressive behavior, or delirium;
• worsening of any respiratory symptoms or if you develop a respiratory infection;
• impulses or urges to behave in unusual ways or an inability to resist the impulse, desire, or temptation to carry out certain activities that could be harmful to you or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating or spending, or abnormally increased sexual desire or thoughts/feelings about sex. Your doctor may need to review your treatment.
• onset or worsening of abnormal body movements (dyskinesia);
• dizziness upon standing (low blood pressure);
• melanoma (a type of skin cancer) or suspicious skin growths or marks.

If you are scheduled for surgery, inform your doctor that you are using Inbrija.

Tests

During long-term treatment with your medications, you may need heart, liver, kidney, and blood tests. If you are having blood or urine tests, inform your doctor or nurse that you are taking Inbrija. This is because the medicine may affect the results of certain tests.

Children and adolescents

The use of Inbrija is not recommended in patients under 18 years of age.

Other medicines and Inbrija

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because some medicines may affect how Inbrija works.

Do not use Inbrija if you have taken drugs called non-selective MAO inhibitors for depression within the last 14 days. These medicines include isocarboxazid and phenelzine. If you are taking them, speak with your doctor or pharmacist before starting Inbrija.

Inform your doctor or pharmacist if you are taking:

• medicines for your Parkinson’s disease called selective MAO inhibitors, such as rasagiline, selegiline, and safinamide; COMT inhibitors such as entacapone, tolcapone, and opicapone; or anticholinergics such as orphenadrine and trihexyphenidyl;
• medicines for mental illnesses including schizophrenia, such as benperidol, haloperidol, risperidone, chlorpromazine, decanoate flufenazine, phenothiazines, butyrophenones, or trifluoperazine;
• metoclopramide for nausea;
• isoniazid, an antibiotic used to treat tuberculosis;
• medicines for high blood pressure, as dose adjustments may be necessary;
• antidepressants called tricyclic antidepressants, such as clomipramine, desipramine, or doxepine;
• amantadine for influenza or your Parkinson’s disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Treatment with Inbrija is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods.

Women must not breastfeed during treatment with Inbrija.

Driving and using machines

Inbrija may cause excessive sleepiness, dizziness, and sudden sleep attacks. If you experience these symptoms, do not drive or operate tools or machinery. Before resuming driving or using machines, you must be certain that you no longer experience sudden sleep attacks, dizziness, or sleepiness. Otherwise, you may place yourself or others at risk of serious injury or death.

3. How to use Inbrija

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting to take Inbrija, you must already be regularly taking a Parkinson's disease treatment that combines a so-called dopa-decarboxylase inhibitor with levodopa.

The recommended dose of Inbrija is 2 capsules for the treatment of an OFF period. Do not use more than 2 capsules for each OFF period. You may use 2 capsules up to five times a day.

The maximum dose of Inbrija is 10 capsules per day.

Important information before using Inbrija:

• Do not swallow Inbrija hard capsules.
• This medicine is used only by inhalation.
• Remove the capsules from the blister pack just before use.
• Two capsules of the medicine must be inhaled to receive the full dose.
• The medicine must only be used with the Inbrija inhaler.
• When opening a new pack, always use the new inhaler provided.
• Your doctor or pharmacist will show you how to use the medicine correctly.

See the "Instructions for use" at the end of this leaflet for guidance on how to use your medicine with the included inhaler.

If you use more Inbrija than you should

If you use more Inbrija than you should (or if someone accidentally takes Inbrija), seek immediate medical attention. You may feel confused or agitated, and your heart rate may be slower or faster than normal.

If you forget to use Inbrija

Use Inbrija only during an OFF period. If the OFF period has passed, do not use Inbrija until the next OFF period occurs.

If you stop using Inbrija

Do not stop using Inbrija without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Seek immediate medical attention if you have an allergic swelling with symptoms such as hives (rash), itching, rash, swelling of your face, lips, tongue, or throat. This may cause difficulty breathing or swallowing.

Seek urgent medical attention if your muscles become very stiff or you have severe muscle spasms, tremors, agitation, confusion, fever, rapid pulse, or marked fluctuations in your blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare, serious reaction to medicines used to treat diseases of the central nervous system) or rhabdomyolysis (a rare, serious muscle disorder).

Seek urgent medical attention if you have bleeding in the stomach or intestines, which you may notice as blood in your stools or darker stools.

The use of this medicine may cause the following adverse effects:

Very common (may affect more than 1 in 10 people):

• cough

Common (may affect up to 1 in 10 people):

• onset or worsening of abnormal body movements (dyskinesia);
• infections of the nose, sinuses, throat, or lungs;
• change in the color of mucus;
• change in the color of nasal mucus (i.e., not transparent);
• throat irritation or itching;
• feeling unwell (nausea); vomiting;
• tendency to fall.

Other adverse effects of unknown frequency that you may experience are:

• sensation of suffocation associated with the impact of the medicine's powder at the back of the throat, immediately after use;
• skin cancer;
• deficiency of red blood cells, causing paleness and feeling tired; increased susceptibility to infections due to low white blood cells; lack of platelets which may cause bruising and tendency to bleed;
• loss of appetite;
• confusion; hallucinations; depression; anxiety; nightmares; insomnia; mental and perceptual disturbances, loss of touch with reality; feeling restless; suicidal behavior; disorientation; exaggerated feeling of happiness; increased libido; bruxism; paranoid or delusional feelings;
• movement disorder where the person's muscles contract uncontrollably; sudden, sometimes unpredictable, changes in symptoms due to the return of Parkinson's disease symptoms; drowsiness; dizziness; worsening of Parkinson's disease; tingling; headache; tremors; seizures; sudden onset of sleep; restless legs syndrome; ataxia (a disorder affecting coordination, balance, and speech); altered sense of taste; mental disorders affecting learning, memory, perception, and problem-solving; Horner's syndrome (an eye condition); dementia;
• blurred vision; double vision; pupil dilation; eyes rolling upward for prolonged periods; strong, involuntary eyelid closure;
• heart problems, a markedly fast, strong, or irregular heartbeat;
• low blood pressure shortly after standing up; high blood pressure; fainting; blood clot in a vein; hot flushes;
• dyspnea; difficulty breathing; speech difficulties; hiccups;
• stomach pain; constipation; diarrhea; dry mouth; stomach or intestinal bleeding; stomach ulcer; difficulty swallowing; indigestion; burning sensation in the mouth; flatulence; change in saliva color; increased saliva production;
• swollen face, lips, tongue, limbs, and genitals; excessive sweating; rash; intense skin itching; a condition called Henoch-Schönlein purpura, whose symptoms include a skin rash with purple spots; allergic reaction causing a rash of intensely itchy red, round spots on the skin; hair loss; change in sweat color;
• muscle spasms; trismus;
• difficulty emptying the bladder; change in urine color; loss of bladder control;
• painful and abnormally prolonged erection;
• swelling of the lower legs or hands; feeling of weakness and lack of energy; feeling tired; loss of energy; difficulty walking; chest pain;
• abnormal blood test results; weight loss; weight gain.

You may also experience the following adverse effects:

• inability to resist the impulse to carry out an action that could be harmful, such as:
  • strong impulse to gamble excessively despite serious personal or family consequences;
  • altered or increased desire and sexual behavior that may be of particular concern to you or others, for example increased sexual drive;
  • excessive and uncontrollable buying or spending;
  • binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more than normal and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviors; your doctor will discuss with you ways to manage or reduce the symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Inbrija Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister packs and outer carton following EXP or CAD. The expiry date refers to the last day of the month indicated.

Store below 25 °C. Keep in the original packaging to protect from light and moisture, and remove only just before use.

Do not use the capsules if they are crushed, damaged, or wet.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Inbrija

• The active substance is levodopa. Each hard capsule contains 42 mg of levodopa. The dose delivered through the mouthpiece of the inhaler (delivered dose) contains 33 mg of levodopa.
• The other components of the powder and the capsule are palmitoyl colfosceril (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, corn starch, shellac, black iron oxide (E 172), propylene glycol, and potassium hydroxide.

Nature of the product and contents of the pack

Inbrija powder for inhalation, hard capsules, consists of a white powder for inhalation contained in opaque hard capsules with "A42" printed in black on the cap and two black bands printed on the body of the capsule.

This pack contains an inhaler together with peelable blisters, each containing 4 hard capsules.

Pack sizes are:

• one pack with 16 hard capsules (strip of 4 blisters) and one inhaler
• one pack with 32 hard capsules (strip of 8 blisters) and one inhaler
• one pack with 60 hard capsules (strip of 15 blisters) and one inhaler
• one pack with 92 hard capsules (strip of 23 blisters) and one inhaler

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Acorda Therapeutics Ireland Limited
10 Earlsfort Terrace
Dublin 2, D02 T380
Ireland
Tel: +353 (0)1 231 4609

Manufacturer

ADOH B.V.
Godfried Bomansstraat 31
6543 JA Nijmegen
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for use: